Scientific Director, NAMs

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ABOUT CRITICAL PATH INSTITUTE (C-PATH)

Critical Path Institute (C-Path) is a nonprofit engaged in the creation of partnerships and innovative processes that improve human health by reducing the time, cost, and risk in developing and approving new therapies. For twenty years, we have partnered with industry and academic experts to advance technologies across the spectrum of medical product development from research to regulatory approval. As a leading nonprofit organization dedicated to fostering collaboration and promoting data sharing in the precompetitive space, C-Path has been at the forefront of numerous advances designed to get new treatments to patients quicker. Our continuing success is made possible by a combination of public and private support from those who share our vision to accelerate a path to a healthier world.

POSITION OVERVIEW

Critical Path Institute is seeking a Scientific Director, New Approach Methodologies (NAMs), to provide scientific leadership and technical support to the Executive Director of NAMs across a diverse portfolio of initiatives. Housed within C-Path's Innovation in Translational Science and Biomarkers Program (iTSB), this role will help advance the development, evaluation, validation, regulatory acceptance, and Fit-For-Purpose application of NAMs to improve drug development and safety assessment.

The Scientific Director will support scientific activities within the NAMs portfolio, which includes the NAMs Developer Coalition (NAMs-DC) and its multiple workstreams; the National Center to Accelerate Cures (NCAC); collaborations with external organizations; and NAMs consulting and advisory engagements involving aligning NAM use with regulatory needs, regulatory document drafting, data coordination, and submission. This role will also contribute to establishing new partnerships, projects, and strategic opportunities as the portfolio evolves.

The successful candidate will combine scientific expertise in NAMs and translational research with sounds regulatory judgment, strong scientific writing skills, practical experience in drug development, and experience coordinating multidisciplinary projects. This individual must be able to critically evaluate emerging technologies, translate complex evidence into actionable development and regulatory strategies, and collaborate effectively with the Executive Director, project teams, technology developers, regulators, and external partners.

SUPERVISORY RESPONSIBILITIES

None

CORE DUTIES/RESPONSIBILITIES

• Assist the Executive Director of NAMs in providing scientific direction, technical review, and execution support across the NAMs portfolio and NAMs Developer Coalition workstreams.
• Support NAMs-DC working groups and member activities, including scientific priorities, technology-specific development plans, evidence gaps, milestones, and deliverables.
• Provide scientific support for the ARPA-H CATALYST project and participating CATALYST teams, including technical assessment, regulatory science input, advisor engagement, and coordination of scientific deliverables.
• Support NCAC initiatives, including the development, scientific review, harmonization, regulatory science input on validation studies, and maintenance of a NAMs Glossary and related terminology or standards activities.
• Contribute scientific expertise to collaborative initiatives.
• Evaluate NAM technologies and proposed applications, including micro physiological systems, organ-on-chip platforms, in vitro models, computational and in silico approaches, and other emerging methods, with attention to biological relevance, reproducibility, robustness, limitations, and context of use.
• Develop and review fit-for-purpose validation and evidence-generation strategies, study designs, performance criteria, data packages, and regulatory engagement plans to support NAM credibility and adoption.
• Lead or contribute to scientific and regulatory writing for NAMs consulting engagements, including briefing packages, meeting materials, qualification or acceptance submissions, responses to agency feedback, reports, publications, and white papers.
• Engage with FDA, EMA, and other regulatory stakeholders, industry scientists, NAM developers, academic researchers, validation organizations, and patient-focused partners to advance scientific alignment and regulatory readiness.
• Collaborate with C-Path Regulatory Science, Data Collaboration Center (DCC), Quantitative Medicine, clinical and nonclinical science, and project management colleagues to align NAMs activities with drug development needs.
• Author internal and external communications, regulatory documents, qualification documents, scientific publications, white papers, reports, and stakeholder updates.
• Foster relationships with key individuals among global regulatory bodies, industry partners, academic investigators, research-performing organizations, patient-focused organizations, diagnostics developers, and other collaborative efforts relevant to biomarker development.
• Identify opportunities for cross-workstream coordination, common terminology, data sharing, method standardization, evidence reuse, and integration of NAMs across C-Path programs.
• Support the development of new NAMs project concepts, consulting scopes, funding proposals, grants, partnership opportunities, and other strategic initiatives.
• Provide scientific direction to project manager(s) and working groups, as appropriate, to support implementation, coordination, tracking, and timely completion of scientific deliverables.
• Travel on occasion for out-of-town meetings, approximately 15-20%.
• Other duties and responsibilities may be assigned.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Demonstrated knowledge of new approach methodologies and their potential applications in nonclinical safety assessment, translational research, and drug discovery and development is required.
• Strong understanding of drug development and the scientific challenges and decision contexts in which NAMs may provide fit-for-purpose evidence.
• Experience with one or more NAM approaches, such as micro physiological systems, organoids, advanced in vitro models, computational toxicology, in silico modeling, or related technologies; ability to evaluate approaches outside one's primary specialization.
• Understanding of NAM method characterization, verification, validation, reproducibility, biological relevance, performance standards, contexts of use, and evidence-generation strategies.
• Working knowledge of FDA and EMA regulatory science expectations and evolving approaches to the acceptance, qualification, or use of NAMs in regulatory decision-making.
• Experience with NAMs applications in toxicology, safety assessment, pharmacology, disease modeling, or translational research is preferred.
• Working knowledge of nonclinical study design, data quality, quantitative analysis, model performance evaluation, and scientific data interpretation is desirable.
• Demonstrated ability to work collaboratively, think strategically, and use an inclusive and consultative approach to problem solving and decision making.
• Demonstrated ability to communicate scientific evidence, technology assessments, validation strategies, and regulatory approaches to technical and nontechnical audiences in both verbal and written form.
• Demonstrated ability to author internal and external communications, scientific documents, regulatory documents, and technical reports that are clear, concise, and fit for purpose.
• Strong interpersonal skills that ensure teamwork and productive interactions among diverse personalities and areas of expertise.
• Ability to garner support and coordinate resources in support of program and project objectives.
• Ability to work independently and lead projects, while retaining the ability to operate as part of a team and incorporate advice and feedback from C-Path colleagues, external experts, regulators, and consortium or program participants.
• Ability to meet target deadlines and manage time effectively, balanced across multiple projects and disease areas.
• Demonstrated aptitude for leading and managing complex teams and deliverables; ability to plan, identify contingencies, course correct, and evaluate project success.

REQUIRED EDUCATION & EXPERIENCE

• PhD, PharmD, MD, or equivalent doctoral degree in a relevant scientific or clinical discipline.
• 3 - 5 years' experience in NAMs, nonclinical or translational research, toxicology, drug development, regulatory science, technology evaluation, method validation, FDA/EMA engagement and/or related research.
• Experience with strategic initiatives and project leadership.
• Experience engaging with regulators or preparing scientific and regulatory submissions in medical product development,
• Experience working in pharmaceutical, biotechnology, NAM technology development, contract research, academic, regulatory, nonprofit, or public/private partnership environments,

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.

Reasonable Accommodation

C-Path complies with federal and state disability laws and makes reasonable accommodation for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact C-Path HR department.

*Critical Path Institute is an equal opportunity employer.*